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BackTable / OBGYN / Podcast / Transcript #37
Podcast Transcript: In-Depth: Endometrial Ablation
with Dr. Barbara Levy
This week on BackTable OBGYN, Drs. Mark Hoffman and Amy Park are joined by Dr. Barbara Levy to discuss the latest advancements in endometrial ablation using cryotherapy. Dr. Levy, a professor at George Washington University and a volunteer at the University of California San Diego OBGYN and reproductive sciences department, has dedicated her career to gynecological advancements. You can read the full transcript below and listen to this episode here on BackTable.com.
Table of Contents
(1) The History of Endometrial Ablation
(2) Evolving Technologies: Cryoablation
(3) The Importance of Clinical Counseling
(4) Procedural Process of an Endometrial Ablation
(5) Long-Term Procedural Impacts
(6) Curating Procedures for Patient Accessibility & Convenience
(7) Treating Uterine Fibroids with Radiofrequency Ablation
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[Dr. Mark Hoffman]
Hello, everyone, and welcome to The Backtable OB-GYN Podcast, your source for all things obstetrics and gynecology. You can find all previous episodes of our podcast on Spotify, Apple Podcasts, and on backtable.com. This is your host, Mark Hoffman, and once again, we have our co-host, Dr. Amy Park. Amy, how are you?
[Dr. Amy Park]
Good. How are you?
[Dr. Mark Hoffman]
Good. Busy, but good busy. The alternative, I guess, would be worse. We have an outstanding guest today, Dr. Barbara Levy, who is clinical professor of obstetrics and gynecology at George Washington University School of Medicine and voluntary clinical professor in the Department of Obstetrics and Gynecology and Reproductive Sciences at UCSD. Dr. Barbara Levy, welcome to the show.
[Dr. Barbara Levy]
Thanks, Mark and Amy. It's a pleasure to be here with you.
[Dr. Mark Hoffman]
We're going to talk about endometrial ablation today. Barbara is a friend and a mentor of mine, so it's wonderful to have not only an expert on the show, but it's always fun to have folks who we're not meeting for the first time on the show. It's an absolute pleasure to see you again and to have you on the show.
[Dr. Barbara Levy]
Thanks, Mark.
[Dr. Mark Hoffman]
We like to start every show allowing our guests to introduce themselves. Please tell us a little bit about yourself, your career, and how you became interested in endometrial ablation.
[Dr. Barbara Levy]
It's a very long career. Are you sure you want that? It could take us the whole time.
[Dr. Mark Hoffman]
We can edit this down. Don't worry. We have great engineers.
[Dr. Barbara Levy]
Excellent. I am an obstetrician-gynecologist. I actually practiced OB for only one year. As soon as I got my boards, I stopped practicing OB and did GYN only for the vast majority of my career. Part of that was just that my interest always was in surgery and minimally invasive gynecology, but also I had an infant, a teenager, and a husband who's a heart surgeon. In addition to running a practice, I was a single mom and obstetrics just didn't work with that at all. I was the third woman OB-GYN in the Seattle area and so none of my patients wanted my partners to deliver them. My partners were men. That all piled up, and drove me to GYN only very early in my career. Then I also had a very unique patient population because I was seeing patients who were unhappy with the gynecologic care that they were getting. It didn't take me very long to figure out that what I had learned in residency probably wasn't right and that my patients were telling me things that I had not heard before. I started questioning a lot of things like, "Gee, how many operations are enough for somebody with chronic pelvic pain? Does lysing adhesions actually do anything?" This is back in the 1980s when we were so excited by laparoscopic surgery that we all just wanted to look in there and see because prior to laparoscopy, we had to do laparotomy. The threshold for those things was quite high.
In any case, I had a very busy and active practice. I was very, very fortunate to be in practice with Dr. Richard Soderstrom, one of the founders of the AAGL. He got me involved in AAGL very early on. I won the resident's prize paper in 1984. I was up on the podium, absolutely scared to death of delivering this paper to a thousand people, but it was my entry into organized medicine. As the years went on, I was elected to the board, worked on the CME committee, and fast forward almost 10-plus years, Harry Rich came along, laparoscopic hysterectomy came along, and we had no codes to describe the things we were doing. We were learning how to do ovarian cystectomies and oophorectomies, and there were no CPT codes to describe those things. AAGL ended up sending me as a liaison to ACOG's Coding and Nomenclature Committee, which was the way the committee was named at that time. That was the start of all of my work in coding reimbursement policy, which has been 25 years or more of working with the AMA, with ACOG.
As the years went on, I was the first female voting member of the RBRVS Update Committee. I became chair of that committee in 2009 and chaired that committee for six years, and then have rotated onto the CPT editorial panel, and I am vice chair of the panel.
I left private practice after a little over 30 years in the same location and was recruited to ACOG to serve as the vice president for health policy and worked at ACOG for seven years, doing our health policy, health economics, global health, maternal morbidity-mortality, quality and safety, trying to build implementation science into how professional organizations work so that, in addition to doing guideline development, we actually worried about how do we get those guidelines to the point of care. It was a wonderful time there, building a team of over 50 people, working on all of these really incredible opportunities to improve health care for women.
In 2019, I left the college and started doing independent consulting, and I'm doing consulting and working for some startups. We're consulting for some big organizations at this point, but also working with AAGL in the EMIGS, the Essentials and Minimally Invasive Gynecologic Surgery, and I'm very proud to say working with ABOG to make sure now that our residents in OB-GYN get to have a GYN-specific skills test and cognitive test to qualify for awards. It's been a lot of work. It makes me tired thinking about it.
[Dr. Amy Park]
It's so amazing, and it's really crazy because all of these changes have happened over such a short period of time, and you've been really here for a really seminal period in OB-GYN. The dawn of laparoscopic hysterectomy, adding the codes, AGL, and then joining these older organizations like AMA and ACOG, that's pretty stellar, and working with ABOG as well. I took FLS, and there's a lot of specific liver and cholecystectomy questions on the portion, and it's just completely not applicable to OB-GYN. The tasks are.
[Dr. Barbara Levy]
Yes, the tasks are fine. The difference is that the EMIGS tasks are within a bowl rather than a square. The female pelvis is not a square box. It's angular, and so the EMIGS tasks are within an angular bowl. We call it the laprobowl for doing those tasks. The cognitive test is far more specific. It is specific to gynecologic surgery and the complications and the energy sources and all those things that we use. Really far better for our residents to be studying those things than learning about splenectomies.
(1) The History of Endometrial Ablation
[Dr. Mark Hoffman]
Your work on the CHECK, it's where you and I first met, where you told me-- it's rare that you meet someone who just changes how you think about everything that you're doing. My time on that committee completely just shifted my understanding of how the healthcare system works, health economics, and all of it, and your constant just support and education in ways that has shaped my career and the work that I'm doing where I am now and hopefully beyond. I'm just so grateful that I got the opportunity to work with you in that setting because it really was an unbelievable room of incredibly thoughtful, hardworking, and brilliant people. I just felt like I got put in the wrong room, and it really felt like a gift to get that education from you guys. That was incredible. Thank you again for that. I'll tell you that every time I see you.
We need to have you come back on just to talk about health economics and coding and things like that. Today, we want to talk about endometrial ablation. Talk to us about endometrial ablation, what you understand of the history of endometrial ablation, when it all started, what that looked like, and how it's evolved.
[Dr. Barbara Levy]
It's another amazing evolution starting with my career. It started with the thought leaders, Milt Golrath and Frank Loffer, who were thinking about ways to manage abnormal bleeding without hysterectomy. In the days when I learned hysteroscopy, I learned how to do things using a cystoscope without continuous flow. That's how rudimentary things were at that time. The beginning of endometrial ablation was really Milt with the YAG laser and using a fiber. You can imagine how tedious that was to take a fiber and try to get the entire endometrial cavity, try not to perforate the endometrial cavity, and then electrosurgery with the rollerball. Again, we used to teach people it's like mowing your lawn, you want to overlap areas. It was really dependent on how thick the endometrium was, the settings of the electrosurgical generator, the size of the rollerball. It was all monopolar at that time. There were a lot of variables in terms of how people did. It all had to be done under anesthesia in an operating room.
Industry got involved and they said, "Well, we can think about some better ways to do this." I actually sat on the OB-GYN devices panel as the FDA was considering what sorts of studies they would require for these concepts of global endometrial ablation. The early studies were randomized clinical trials, randomizing people to rollerball or the newer technology. The first one out was the balloon, ThermaChoice, which was reasonably good, but it was still heat. There were, I will say, enthusiastic OB-GYNs who did it in the office. They had very tolerant patients. Most patients in the United States would not tolerate the heat in an office setting without analgesia of some kind. It really took off the concept that you didn't have to have this great skill set in hysteroscopy, because frankly, to get a rollerball up into the cornu to make sure that you were getting the entire cavity, to make sure that with full duration, with electrosurgical energy, you can toast the surface and not get deep. You really had to have a deep understanding of electrosurgical energy to understand how fast to move the rollerball, how to overlap, how to do it.
The results were variable. The concept of global endometrial ablation was awesome. It was a way to democratize, if you will, that all OB-GYNs would be able to do this kind of procedure. In the early days, the early studies were very limited in terms of who were the right patients. The patients had to be ovulatory. They had to have a relatively normal-sized uterus with no fibroids. Those were the initial inclusion criteria for the randomized clinical trials. Then as more and more of these devices came on market, FDA became more comfortable with doing single-arm studies and comparing retrospectively to rollerball, which was an easier study to do for people in industry. The whole concept of endometrial ablation was always to reduce heavy menstrual bleeding to normal or less. The concept of creating amenorrhea was actually never the goal. The goal was to reduce heavy menstrual bleeding to the point that we could avoid hysterectomy. That's a baseline history.
[Dr. Mark Hoffman]
How did rollerball become the standard without such rigorous testing? It seems like it was just grandfathered in or was it just people doing it?
[Dr. Barbara Levy]
Yes. In the 1980s and early 90s, things that had always been used were grandfathered, but it was also that there wasn't a specific device that had to be approved by FDA. There was an instrument. The rollerball was an instrument that went onto the hysteroscope, but it wasn't a medical device in the true definition of how FDA-- I'm sure the rollerball had a 510 K because it's the same as a ball you would use at an open procedure, a ball electrode.
[Dr. Mark Hoffman]
Is there a urologic use for rollerball or is that something that was made specifically for gynecology or do you know?
[Dr. Barbara Levy]
I don't know, but you could imagine that it probably was used for coagulation of bleeding in the bladder or at the prostate, prostate bed, if people were doing prostatectomies. I don't recall there being some, "Oh, look at this new instrument." I just recall that we had loops and we had rollerballs and that's what people used. I think the YAG was a little bit more problematic in terms of approval, except that YAG lasers were already approved. FDA was in its infancy in terms of devices. On the pharma side, the FDA has been around for a really long time, but the Devices Act actually grandfathered a lot of things on the device side.
[Dr. Mark Hoffman]
That seems like a whole other episode where we could talk about 510 Ks and FDA and all that stuff.
[Dr. Amy Park]
I haven't done hysteroscopy in a long time, but you're coming up against-- I'm just thinking back of all these innovations just in hysteroscopy. I trained in rollerball and I remember when the ThermaChoice and the balloon came out and the NovaSure with the cornu and covering the cornu because of the shape and all of these other things that actually precluded the need for worrying about a fluid deficit, bipolar energy, and using saline instead of these hyperpolarized molar fluids. I forgot about all of this stuff, but we've seen a lot of stuff in the last 20 years.
(2) Evolving Technologies: Cryoablation
[Dr. Barbara Levy]
We have. The MAW database, which is the database where complications are theoretically reported to FDA, and manufacturers are required to report when they know about a complication, but we as surgeons and hospitals don't have that same regulatory requirement. We know that the MAW database is not complete, but we started to see some complications related to something like bipolar mesh device that sucks on the uterine wall and then delivers deep energy. As we think about our patients who've had five C-sections and their risk of dehiscence, we can think about how thin that uterine scar might be. We started to see burns. We started to see bowel injuries. We started to see some things.
Along came cryoablation. Cryoablation always sounded really great to me because you were freezing and therefore numbing the nerves as you were doing the procedure. It was much more tolerable in the office, but it was a very kludgy system. It was called Her Option. It was that you had to create ice balls throughout the uterine cavity overlapping under ultrasound guidance. You were determining how deep, how big an ice ball to do. Then you had to thaw it. Then you had to go in another location and then you had to do it again. It took quite a long time. It was ultrasound-guided, but it did work.
What I loved about it was that patients were super comfortable. The only uncomfortable part of that procedure was the initial dilation, which was only-- I don't remember exactly how big the dilator was, but it was maybe six millimeters. It wasn't eight or nine. Cryoablation had a little bit of a following just among the people who like to do procedures in the office. Again, there were people who were doing the heat procedures in the office, but as time went on, I think our office staff and our nurses, and others complained a lot about patients-- It's really bad for business when people are screaming in the office. People in the waiting room don't like to hear that.
It became more standard for people to engage with anesthesiologists or nurse anesthetists and to do IV sedation, which added risk and added time to those procedures. It still was financially lucrative to do them in the office because all of-- Mark, this is to all of the things we talked about at CHECK--All of the overhead costs of doing those procedures is covered when you do them in the office. When you do them in a facility, whether it's an ASC or hospital outpatient, the hospital or the facility is getting all of that payment for all of those things.
[Dr. Mark Hoffman]
I don't know that I've seen an office endometrial ablation. I remember rollerball. I remember having to make sure patients didn't get pressed after their-- before we were using saline and things like that. Most of what I see now is in the OR. Talk to us about the options. What are people using now? What are the most common and what's available that people are maybe using less frequently and how do they compare?
[Dr. Barbara Levy]
There are lots of options out there. Companies have seen the 200,000 or so cases that are being done a year and recognize that that's a reasonably good market. Women will continue to have heavy menstrual bleeding. Again, reasonably good market. What we have now are a bunch of heat technologies, whether they're steam, there was microwave for a while, there's still the bipolar mesh, which is very, very popular, but really painful. It is short, but it's really, really uncomfortable. I don't know anyone in the United States who's doing that procedure without IV sedation. Now, there are many practices that are doing IV sedation in the office. To me, that means now you have to have a recovery area and you have to have an RN that's dedicated to watching that patient. You have to make sure she has a ride home. There's a lot of infrastructure and overhead that goes into trying to do that.
About 10 years ago, a company got started looking at how they could do cryoablation more effectively, efficiently, and really make it an office procedure that worked. A lot of engineering went into this current cryoablation technology, which is called Cerene. Again, I'm a big fan of cryo, both for the anesthetic aspects of it and something we didn't mention before, but the healing of the endometrial cavity post-ablation is different after freezing than it is after heat. I can't explain to you the why, but I will tell you that most of the amenorrhea associated with the heat technologies is related to the creation of Asherman's. It is that the walls of the uterus stick together. We know that the post-ablation syndrome often comes from little islands that are still active above an area of dense scarring that cyclically will create severe pain.
Access to the uterine cavity-- Again, as a doctor who practiced in the same community for 30 years, I followed my patients across the lifespan and it always bothered me that I was doing something or I might be doing something that would preclude my ability to evaluate my patient long-term. What if she had an episode of abnormal bleeding five years after the ablation? How am I going to work that out? How am I going to evaluate that? Can I see the entire cavity? Can I feel confident that if I'm sampling something that she doesn't have cancer in there?
[Dr. Mark Hoffman]
I think that's why a lot of us in the MIGS world think a little bit more about global endometrial ablation maybe than others because we see so many of the complications. I don't mean allergy-type complications, but maybe the failures more so than the complications with the patients who undergo it and they have pain afterwards, whether it's post-ablation syndrome, whether it's failure, whether it's eight years later, they're menopausal and having bleeding and I can't sample the cavity and the ultrasound doesn't tell me much of anything. The lining is--
[Dr. Barbara Levy]
Well, you try to put a hysteroscopy in there and you just--
[Dr. Mark Hoffman]
You hit a wall.
[Dr. Barbara Levy]
Yes. It's seriously Asherman's syndrome. For me, cavity access is a major distinguishing feature of cryotechnology compared to heat of any kind.
[Dr. Amy Park]
What do you see when you go back in afterwards because I've only-- after post-ablation with heat, it's stuck together, it's fried.
[Dr. Barbara Levy]
It's a mess. The long-term follow-up for Cerene specifically was over 90% ability to see the cavity long-term. For me, that's really a big plus.
[Dr. Mark Hoffman]
What does that compare to other modalities, like 90% compared to--
[Dr. Barbara Levy]
They haven't even done those studies. Cavity access is-- because that's bad news for them. Everything Amy just said is exactly what happens. You try to put a scope in there and you just see adhesions, you see scars, and it's part of the mechanism of action. They work really well when they work well for that reason.
[Dr. Amy Park]
I'm not a usual ablation person. I actually presented SGS and I published something in fellowship with Linda Bradley about post-ablation-- actually uterine artery embolization complications, but also there was along those lines during that same period in the late 2010s era with all those sequelae of abnormal vaginal discharge, prolapsing fibroids or dyspareunia, persistent bleeding, the post ablation tubal syndrome. I've seen that a couple of times.
[Dr. Barbara Levy]
It's devastating. It's really bad.
(3) The Importance of Clinical Counseling
[Dr. Amy Park]
The cyclic pain with the persistent endometrial tissue at the cornua and the dilating up the tubes causing these hematocele pains. It's pretty painful and causes a lot of discomfort. I just remember going, "Well, I'm not sure," and then a lot of obese patients were getting it, and that was the contraindication. I agree with Mark. I just saw a lot of patients coming through. It seemed like, "Why not just get an IUD and then hysterectomy?"
[Dr. Barbara Levy]
Remember that in the early days of endometrial ablation, the Mirena IUD, the levonorgestrel IUD didn't exist. That came along later and absolutely in my practice, I would 100% recommend to patients that-- because you still need permanent contraception if you're going to have an ablation. To me, the first line of treatment was always to think about a levonorgestrel IUD for sure.
That said, I will say that the other thing that happened across the years is that the strict criteria that FDA originally used for the pivotal trials, ovulatory patients with a normal-size uterus and no fibroids got expanded. They got expanded now to small fibroids and maybe some polyps. Then some of the studies did not require that the patients were ovulatory and that's where we really start to get into trouble because now you've got patients who are at least somewhat anovulatory and at risk long-term for hyperplasia or endometrial cancer.
Now, there were thought leaders who said, "Well, if I destroy the whole endometrium then we're reducing their risk of endometrial cancer." Most of us were saying, "Yes, but you never really destroy the entire endometrium. Does that cancer actually start from the superficial or does it start from the basalis?" Who knew? What happened was, of course, this industry does what industry does, they start promoting this and expanding the indications for doing this procedure.
Patients loved the idea of no hormones. It was a way of sucking women in. Then one or two of the companies really started pushing amenorrhea as the endpoint and the thing that was really meaningful. Most studies, in fact, every study that I'm aware of that asks women what they want, they want a return to normal or a little bit less than normal. Amenorrhea is not an endpoint that most women in focus groups and other things are looking for. In fact, culturally, some women absolutely do not want amenorrhea. In my practice, Amy, there were women culturally who would not have a foreign body in their uterus. IUD is not an acceptable form of treatment for a certain population of people.
[Dr. Mark Hoffman]
There's a lot of patients in my practice who the idea of an IUD scares them. I'll have patients who have unbelievably long lists of terrible medical comorbidities and dozens of surgeries and they go, "Oh, well, an IUD scares me more than a hysterectomy." I said, "Well, then my job is to educate you to the point where you're more scared of the hysterectomy than the IUD because it is amazing how--" Again, we're education. We're not journalistic. We want to make sure we inform our patients, but I do think the other thing with education, as it relates to endometrial ablation, is I have a lot of patients that come see me that, "Well, I was told I wouldn't have periods." The counseling is not what the device manufacturers recommend, what any of the evidence suggests that people want, nor is it the thing that any of the studies are looking for which is reduced bleeding or amenorrhea. Amenorrhea is sometimes a side effect and patients are going, "Well, I didn't want to have a period anymore." I said, "Well, but then your doctor shouldn't have told you you weren't going to have the periods."
[Dr. Barbara Levy]
That is not appropriate counseling for the Mirena IUD or the levonorgestrel IUD, nor is it appropriate counseling for endometrial ablation. If a patient really wants guaranteed amenorrhea, the only way we can guarantee that is with a hysterectomy. I was very clear with my patients about that.
[Dr. Amy Park]
Isn't there a high rate of hysterectomy, post endometrial ablation? Do you know what that rate is? Is it in the range of 20% to 30%? Is it 50%?
[Dr. Barbara Levy]
Yes, it's somewhere between 17% and 25%. It all depends on how many years you go out and what were the inclusion criteria for the patients. The more obese, young patients you include in your study, the higher your rate of hysterectomy is going to be. The right patient for an endometrial ablation is someone in her 40s who's completed childbearing, who maybe has a partner with a vasectomy, or she's had a tubal sterilization and she wants reduction in her heavy menstrual bleeding and would be happy with hypomenorrhea, but we're not promising amenorrhea for anyone. We shouldn't be because the real data on endometrial ablation of any kind is that, yes, amenorrhea may be a side effect for some, and that may be the cause for many people of their severe pain in subsequent months.
[Dr. Mark Hoffman]
For patients who are getting thermal ablation, are there any things that they or their providers can do to minimize their risk of Asherman's? Do you know if estrogen or IUDs or those kinds of things can be helpful for--
[Dr. Barbara Levy]
No. They're not approved for the use of an IUD post-ablation. We don't know what perforation rates would be or what would happen. There are some companies out there looking at hyaluronic acid or putting some sort of gel inside the uterus. Those are investigational things, none of which are available currently. Currently, we don't have anything that anybody knows of that works.
Estrogen works for people with Asherman's syndrome who want fertility, but you're not applying heat. You're very specifically not damaging tissue with heat when you're treating Asherman's syndrome for fertility. I'm not at all sure that with the destruction of the endometrium down to the basalis that estrogen would be helpful. I don't know of anybody who's tried it, but it would be a tough study to do because you'd have to be doing hysteroscopy periodically three months, six months, a year later, and you'd be treating people with pretty high doses of estrogen for, I don't know, six weeks for however long the healing period would be.
(4) Procedural Process of an Endometrial Ablation
[Dr. Amy Park]
Just for my knowledge in terms of the popularity and uptake of endometrial ablation and who's doing it, what is your sense, or what do the stats stay? I don't know.
[Dr. Barbara Levy]
Yes. It has declined with the increasing use of the levonorgestrel IUD. It's definitely not in its heyday as it was, although there's a lot of new technology out there. I think that it's been relatively stable. These numbers are hard to come by because even the Medicare database isn't going to help us at all, the Medicaid database isn't going to help us at all. We have to look at all payer databases, which are really expensive to try to get a handle on it. It looks like somewhere around a couple of 100,000 cases a year.
I think that if cryoablation really takes hold and people recognize that they can do a procedure in a 15-minute office slot with no additional help and the patient is comfortable and goes home right away and goes back to normal activities, that probably will drive more because the threshold for a patient, the cost to a patient to go to an outpatient facility, whether it's an ASC or an outpatient hospital facility is going to be substantial. They have a percentage of total cost that they will have to pay versus a $25 or $35 copay in the office and that's it. There's a big cost difference for patients and I think there's also that threshold. If you're going into the hospital and you're having an anesthetic, I would be a little antsy about that versus being in your own physician's office where you have a comfort level and could have a procedure that's not more really than putting in an IUD.
[Dr. Mark Hoffman]
You're saying with cryoablation, that's something that I’ve not seen done in my practice. It's not something I've seen in training. It's obviously something new that we're here to talk about a little bit but talk to us a little bit about the device. I think Cerene is what we're talking about, because yes, endometrial ablation is in the OR in my practice. It is something we are not doing in the office. We're not talking about doing in the office, whether it's at the ASC or OR, people are undergoing anesthesia, there's a recovery period and what you're saying. I've read a little bit about it, but I'm not very well versed on cryoablation or the new devices coming out, but talk to me about what it is, how it works, are we dilating, all those things. Just walk us through how this procedure gets done.
[Dr. Barbara Levy]
First of all, it's a handheld device with no capital equipment required. There's no big generator or something to purchase. It's all a self-contained single unit. It has a canister of gas. So, what happens is the patient comes in, we do our usual, "Hello, how are you?" and we've already talked to her about endometrial ablation, so she's prepared. If she is someone who has irregular periods, we're going to want to treat her at the follicular phase or with a thinened endometrium. You really want that endometrium to be at an early follicular phase in terms of thickness. The device itself is about 5.5 millimeters, so it's about the same as the IUD in terms of dilation.
It is deployed, you measure the cavity, it deploys a liner that conforms to the shape of the uterus. It can conform around a polyp or in an irregularly shaped uterus. It's like a balloon, they call it a liner because, unlike a balloon, it's not round. It actually uses a very slow increase in gas pressure to conform to the irregularities in the lining of the uterus. It's amazing. They've got this all mindless. It's all in the handpiece. It tells you what to do, what's the next step, and tests for integrity of the uterus to make sure that the uterus is intact. Then, it slowly increases this gas pressure so that she's not feeling a sudden onset of pressure. As the gas expands, it cools. It gets to maximum temperature or minimum temperature quite quickly. The entire procedure is about seven minutes.
Patients tell me that they have less discomfort than with the placement of an IUD because they don't get that cramping. Most of the docs who were doing the pivotal trial used NSAIDs rather than a paracervical block. If people are used to doing a paracervical block for an IUD, I would say do it. I would say for multiparous vaginal delivery patients who have an OS that's accessible and pretty easy, probably not necessary. For somebody who's had four C-sections, you probably want to do a paracervical block because you may have some trouble dilating. Some used NSAIDs and that's it in terms of pretreatment for the patients.
It is also the original cryoablation procedure. Remember the ice ball, Her Option, had within the code ultrasound guidance because you had to have ultrasound guidance for that procedure. To use that code without a modifier, putting a transabdominal ultrasound probe just to make sure that you're in the right place or you're aiming correctly in a retroverted or anteverted uterus allows you to use that cryoablation with ultrasound guidance code that's been in existence for a long time. The patients are very comfortable.
[Dr. Mark Hoffman]
Do you ultrasound every patient?
[Dr. Barbara Levy]
It's not that you have to do ultrasound guidance, but yes, you put the ultrasound on just to see, "Where's my probe? Is it in the right place?" which is reassuring, especially with a really retroverted or anteverted uterus. Patients are really comfortable during the procedure. Importantly, they're really comfortable after the procedure.
My experience with the heat ablation rollerball or the others is that the release of prostaglandins as the destruction of that endometrium happens, and Amy, this was really true with uterine artery embolization. Patients have really severe pain for 24-48 hours afterwards and patients call the office and they're really uncomfortable. That doesn't happen with cryoablation. Again, I don't know enough of the basic science or the physiology to say why it doesn't happen with freezing, but it doesn't.
Patients do have a bit of a watery discharge for a few weeks afterwards. It's not as much as it was with the Her Option. Her Option was a lot of copious and anybody who ever did cryo of the cervix, I know I'm really dating myself now before leap, but they had a lot of watery discharge. This is some, but not as much, and we just tell patients to expect it.
[Dr. Amy Park]
Then the way you described it was so evocative. Is it like that squishy little ball that my kids get. It makes it sound like it's conforming like some--
[Dr. Barbara Levy]
Yes. It is. The engineering is really, really remarkable for how they did this and how they really thought through what are the things that make women hurt. You could do this procedure faster if you just jacked up the pressure right away. They said, "Yes, we'll just slowly increase the pressure so the uterus gets used to it," because it uses a combination of the cooling and the pressure to get a very uniform depth of freeze.
[Dr. Amy Park]
How much do you have to dilate again?
[Dr. Barbara Levy]
5.5.
[Dr. Amy Park]
Oh, that's not bad at all. You just dilate up to 20 French or something?
[Dr. Mark Hoffman]
You're probably not dilating on very many people then I'm guessing, if it's like an IUD.
[Dr. Barbara Levy]
Yes. It depends on the patient. As I said, if she's had a bunch of C-sections, never had a vaginal birth, you may have to dilate her. Some people have really stenotic cervices after C-section. I think it depends on the patient. Somebody with a history of atypical hyperplasia, I think I would counsel very carefully somebody who's under 30 because it just doesn't last forever and ever and ever. The benefits do diminish with time, I think, with any ablation procedure. All of the studies show the best outcomes in people in their 40s. If she's younger, I would say, "Maybe this isn't the best option for you." Someone who's not willing to say that they've completed their childbearing, if they want an option, the last thing any of us who still do obstetrics want is to manage a patient's status post-ablation who gets pregnant and has a placental abnormality and accreta. That's just not what you want.
[Dr. Mark Hoffman]
Any number of C-sections with this?
[Dr. Barbara Levy]
C-sections were allowed in the pivotal trial for Cerene and again, your ultrasound will help you because you can look at the scar. There was a measurement, I think the myometrium had to be at least a centimeter in the trial for FDA. That was a safety thing. I think, again, ultrasound helps you know that. If you put the ultrasound on somebody and you can see right into the cervical canal and they got nothing, that's probably not the best patient for any ablation procedure.
(5) Long-Term Procedural Impacts
[Dr. Mark Hoffman]
What's the longest you guys have followed these patients?
[Dr. Barbara Levy]
Published data is at three years. Patients are certainly at this point six-plus years out, I think. Long enough for me to be comfortable.
[Dr. Mark Hoffman]
You mentioned Asherman's being far, far less common with cryo versus thermal ablation. Is there a place for repeat ablation for these patients with this device? I know it sounds like it's probably not been out long enough for it to be studied, but would that be a potential benefit or is there a role for that?
[Dr. Barbara Levy]
Yes. I think there are two really, really cool studies to do. One is a repeat ablation. You'd want to do an IRB-approved, inform your patients that this is not standard of care. I see no reason why you couldn't do it because you have cavity access to the whole cavity. It should be doable. Then the second one is, to Amy's earlier point, what about doing the ablation and then putting a levonorgestrel IUD in, not to prevent Asherman's, but for contraception, or a non-levonorgestrel? What if you put in a non-hormonal IUD in patients that are not good candidates?
Breast cancer patients are really good candidates. Breast cancer patients who have heavy menstrual bleeding either during their treatment or post-treatment. Young people sometimes get their periods back and we can't use hormones to manage their bleeding. Other cancers, people with leukemias and who are under treatment and have very heavy bleeding, ablation is a great technology for them.
[Dr. Mark Hoffman]
Patients who want control over their reproductive future and aren't good surgical candidates for salpingectomy or sterilization to be able to provide them with long-term contraception when they may not be able to get salpingectomy or a tubal sterilization and their partners.
[Dr. Barbara Levy]
Just to be clear though the ablation is not contraceptive.
[Dr. Mark Hoffman]
No, that's my point, it's not contraception. In patients who don't or aren't able to get permanent sterilization, being able to potentially, again an important study to think about in the future, is to be able to potentially do an intrauterine device.
[Dr. Barbara Levy]
I would love to do that study.
[Dr. Mark Hoffman]
That'd be interesting.
[Dr. Barbara Levy]
I would love to do that study. I think that saying to a patient especially these days where we don't have hysteroscopic sterilization available anymore, saying to a patient, "Well you need some permanent kind of contraception," especially if she's not partnered at the moment, that's another counseling thing.
[Dr. Mark Hoffman]
Their partner can get a vasectomy. What if they've got more than one partner? We make a lot of assumptions when talking to our patients but-
[Dr. Barbara Levy]
We do.
[Dr. Mark Hoffman]
I think having our patients-- providing them the opportunity to have reproductive choice and control over their reproductive features to make whatever decision they want without relying on a partner. That's a big part of it I think for many of our patients.
[Dr. Barbara Levy]
For now, to say that you need to have a surgical procedure for sterilization is a hard thing to say to people unless they're having a procedure anyway for some other reason. I think endometrial ablation has a place, I think it has a place in the right patient population. I also think a lot of our patients do not complain about heavy bleeding because they've had it their whole lives and they're not aware. There's no benchmark for it.
Mark Monroe and a whole group of people published a paper fairly recently about the incidents of iron deficiency in the reproductive-aged women. It's dramatic, it's really high. Women tolerate an awful lot without much complaint, and it does majorly interfere with quality of life. There's a very large group of patients who are told their only option is hysterectomy and that makes me really really sad.
[Dr. Mark Hoffman]
Most of us in the MIGS world have those patients who come to see us for that second opinion and we get to offer them a bunch of things that no one's ever told them. It's frustrating and it's sad, but also it's nice to be able to be the one to offer them those solutions. That's part of what we do, is to try to be experts in all the different approaches so we can offer whatever each patient needs in that moment or whatever they want in that moment.
[Dr. Barbara Levy]
The unintended consequences, I'm not sure we're generally aware. I'll tell you the story of a patient of mine in my telemedicine practice, who had heavy menstrual bleeding since adolescence, went to see a doctor who said, "Your only choice is hysterectomy." She never went back. She never sought care because she didn't trust anybody. Fast forward about 10 years and we saw her after her trip to the emergency room with loss of consciousness with her period, her hemoglobin was four. That's just a travesty, that should never have happened, but we don't realize that patients in their heads say over and over and over again what we tell them and then we lose their trust. Being really careful to tell a patient about all options I think is a really important message to all of our colleagues.
[Dr. Amy Park]
It is interesting about like if you only have one tool in your toolbox that's what you end up recommending, and it's such a lesson listening to you guys to just remember that it's just really important to have a lot of tools in your toolkit, in your armamentarium because patients have choices and this is ultimately a quality-of-life issue. Yes, you can get deathly ill from of course this severe anemia but people have some legitimate fears and concerns. Just parallel to the Mesh story for slings now that we have other options, patients are really, in terms of the Bulkamid urethral bulking, people really are going for that a lot more. It's important to respect the patient's autonomy and not push an agenda or a procedure, patients can sense it out right away.
[Dr. Barbara Levy]
They can. To your point, you bring up another really good point and that is for us as physicians, we need to be thinking about the long-term consequences of things that we do. Mesh is another great example of what could happen to my patient down the line with this. Again for me personally the inability to access the cavity five years from now in a patient with an abnormal bleeding episode, that worries me and it bothers me. When there's an option to do a technology that's equally effective but preserves the cavity, that would be my choice for that reason. Not the immediate differences, because immediately there's not that big a difference in their outcomes, but what's it going to be for my patient five years from now or 10 years from now?
(6) Curating Procedures for Patient Accessibility & Convenience
[Dr. Mark Hoffman]
I think that's huge, and I think most of our patients are not ideal patients. When we're talking about size, risk of endometrial cancer, and those things, our country is getting bigger, the rate of endometrial cancer is going up as we all know for that very reason. The other thing when you talk about doing this in the office though, as you talk about this that we all start spending a little bit in my head because as I've talked about in the show I've spent some time working in Eastern Kentucky and rural practices and patients getting up to see me is not a small deal. These are patients that are working, that getting time off, and pre-ops, and post-ops, and anesthesia, and getting a ride, all of these things are--
[Dr. Barbara Levy]
They're barriers.
[Dr. Mark Hoffman]
They're huge barriers in ways that certainly until I went out there and talked to folks and experienced that as a provider to realize that they would rather live with what they were dealing with where they were than to have to make multiple trips to see me, even though maybe it's just a couple of hours. It's a huge barrier. These are being done in the office. The patients need no anesthesia. Are they leaving like they got an IUD, they're able to go back to work, in theory, that day or is it a bit more than that?
[Dr. Barbara Levy]
No, no, it's quite similar to having an IUD placed.
[Dr. Barbara Levy]
That's amazing.
[Dr. Mark Hoffman]
It's not what I'm used to when I'm thinking about endometrial ablation, it's not what we're doing, every program I've built I think, I have to build this with our rural patients in mind, because if it works for them, then everybody else will just consider that VIP care. To be able to do a procedure in the office with no downtime, without a ride, without asking two people to take a day off work or whatever it is, those are big barriers that we need to think about more often, I think as surgeons.
[Dr. Barbara Levy]
We also, Mark, have to think about access issues from the provider standpoint too. When we leave our office to go to a facility to do a procedure, it's incredibly inefficient. Even if you have block time, you're waiting on anesthesia, you're waiting on recovery, you're waiting on whatever, whatever.
[Dr. Mark Hoffman]
Turnover, cleaning, all of it.
[Dr. Barbara Levy]
Versus being able to do something in a standard 15-minute office slot, that's dramatically different in terms of the cost to your practice, the opportunity cost. What is it really costing you to do an endometrial ablation in a facility setting?
[Dr. Mark Hoffman]
It's different. It's absolutely different.
[Dr. Amy Park]
A lot of people just do Botox in the ASC and I'm like "Oh no, we are instilling lidocaine, indwelling lidocaine, 20 minutes, Pyridium, glycogen. If you want some Ativan and Percocet I'm happy to give it to you, because that's better than getting injected with some drugs and taking you half a day because patients' time is precious.
[Dr. Barbara Levy]
Just think about the patient. It's not only her time for the procedure but to Mark's point, she has to have a pre-op. She has to take time to do all of the paperwork and the anxiety of being in a place that's not familiar, versus being in your doctor's office where you know the people and you know the front desk, and the anxiety of not knowing what it's going to cost. Knowing that if it's in the office you owe an office copay and that's it versus you've got the anesthesiologist, maybe you have pathology, you've got lab and you've got the facility fee all of which you have to pay a percentage of, and then the physician fee as well. We don't think about the delta in cost to the patient but it's significant.
[Dr. Mark Hoffman]
If a patient is being referred to you, they've already had their Pap, they've already had their endometrial biopsy, they're coming to see you for this procedure, you could in theory do it if they're coming for that the day you meet them?
[Dr. Barbara Levy]
You could. I never like to operate or do anything on somebody I've only met once, but for rural patients if we can--
[Dr. Mark Hoffman]
Or do a telemedicine visit to meet them.
[Dr. Barbara Levy]
Exactly.
[Dr. Mark Hoffman]
You could do a lot of that stuff which we're trying to do now for a lot of our surgical patients. They know what they're getting, "Here's who I am, here's what I think we can do," and they're prepared. You don't like to meet anyone the day you operate on them, but at the same time these patients, they need care, and where they are a lot of these places are care deserts. To be able to come up and get destination care within your own state in America, not a lot of us think in that way, but I certainly do. This definitely could add something to our practice. It's very interesting.
(7) Treating Uterine Fibroids with Radiofrequency Ablation
[Dr. Amy Park]
I know this is different but I just have to ask you guys as experts in the field about radiofrequency ablation. Is it just for zapping a fibroid? How does that work?
[Dr. Barbara Levy]
Radiofrequency ablation for fibroids is not dissimilar to radiofrequency ablation for liver tumors, lung tumors, or kidney tumors. It's been around a very long time. It's a destructive energy delivery system. The two that are on the market now for fibroids are ultrasound. There's a lot of machine learning that went into helping the algorithm to know exactly how long to deploy the radio frequency. It's made them far safer. In the old days, we would just randomly stick needles in and key the electrode for a while and look at it and decide, Oh, it's cooked or it's not. We don't do that anymore. These two newer technologies are very specific. They can see fibroids that we would not be able to see.
One of my problems with laparoscopic myomectomy was always the lack of my ability to feel for the princess in the pea, the fibroids that were in the myometrium that I couldn't see on the surface. Now with intra-abdominal ultrasound or intracavitary ultrasound, they're able to see all these little fibroids. I think, again, it's a democratizing technology. People who are not skilled enough to do myomectomies which are hard. You have to think through the operation. They're bloody. You have to be able to suture and suture well. This democratizes the ability to treat uterine fibroids without hysterectomy among anybody who can do laparoscopy or hysterectomy.
[Dr. Amy Park]
Instead of global endometrial ablation that we're talking about, this is really focused towards--
[Dr. Mark Hoffman]
The two devices that are out there. One is laparoscopic. You've got a camera, you got a port for a camera. You have a port for a laparoscopic ultrasound probe that goes onto the uterus and a needle, basically, that goes through the abdominal wall and into the uterus. These little tines come out into the fibroids and you're watching it through the ultrasound probe to make sure that it's in the right spot, that it's cooking, the time, and all those things.
The transcervical approach to me is more interesting because that's still laparoscopy. It's still an abdominal entry. It's still a big procedure. Like Barbara said, myomectomy is a big surgery. I don't care how minimally invasive you do it. There's always those small fibroids, one, two-centimeter fibroids, or the asymptomatic three, four-centimeter fibroids that are there. You know they're going to grow, but do I want to do this big procedure on somebody if they're asymptomatic? Transcervically now, the ultrasound probe goes in through the cervix and the probe comes parallel to that and you can watch it through the ultrasound directly into the fibroid. Now, I'm making no incisions. The fibroids that I was going to maybe, "Do I just leave that alone or watch it?" I can get them while they're small and they never become big. That to me is a pretty radical change in thinking about how much we just go, "Oh, you have small fibroids, they're asymptomatic, ignore it, it's normal." It's not normal. It could become a problem later, or they're mildly--
[Dr. Barbara Levy]
Yes, I would argue that I would never operate on an asymptomatic patient.
[Dr. Mark Hoffman]
Asymptomatic, but not as symptomatic. Symptomatic, but they don't want a big open myomectomy or a lap myomectomy, and they're all looking for something else. Thank you for that clarification. No, 100% agree, but you're more likely to offer a procedure that is less invasive, no incision, same-day surgery. You brought up uterine artery or uterine fibroid embolization. That is ischemic necrosis of the fibroid, which ischemia is very, very painful versus RF ablation destroys fibroids via coagulative necrosis. It's not as painful. It's like our patients in our UFU program are admitted overnight, PCAs or regional anesthesia. It's very painful overnight. Even though there's no incisions, the pain is enough that they're actually admitted overnight just for pain control in our practice. Whereas for RF ablation, same-day discharge, NSAIDs, they're not really having anything close to the pain that they experience for uterine fibroid embolization.
[Dr. Barbara Levy]
Yes, what I love the most about it is, exactly to Mark's point, you can treat all the fibroids that are there. Once a patient needs a procedure for her fibroids, being able to treat all of them will avoid the reduce that happens when you can't see those ones that are pushing towards the cavity.
[Dr. Amy Park]
Got it. I don't know exactly the details. I knew it was a new hot technology and people are starting to do it. I love that about the minimally invasive gynecology crowd. We have innovation in urogynecology, of course, absolutely, but fibroids and abnormal uterine bleeding have been such a sticky problem for so long. There's truly some big advances in the field.
[Dr. Mark Hoffman]
We'll have to have a whole other episode on fibroids and new technologies because we're just getting the transcervical ablation device where I am now. We'll be starting that soon. Hopefully, I'll have done it by the time this episode airs. That's something I've been following for a very long time. It is something that I think will pretty dramatically change the approach.
[Dr. Barbara Levy]
It's evolved. Since the original design, it's far better than what the original thoughts were about it. I'm very excited about either the laparoscopic or the transcervical as opportunities for general OBGYNs, not necessarily mixed-trained, to be able to manage fibroids without telling every woman she needs a hysterectomy.
[Dr. Mark Hoffman]
As always, Dr. Levy, I learn a great deal whenever I get the chance to chat with you. It's always a pleasure. I'm so grateful for our friendship and your mentorship and my luck in getting to work with you over the years. It's been an absolute pleasure tonight, as it always is, to have the opportunity to chat with you. Thank you so much for coming on the show. It's been so much fun, as always.
[Dr. Amy Park]
You're awesome. Thank you so much. I've just been so inspired by you and just being a part of this journey with you has been awesome. I'm so glad you're continuing to do all the great work that you're doing. You always have curiosity and you always have this desire to see things pushed forward, which I hope I can sustain as well because I think it just keeps you young.
[Dr. Barbara Levy]
You are both quite young and you both have that curiosity. Thank you really for having me. It's been a pleasure.
Podcast Contributors
Dr. Barbara Levy
Dr. Barbara Levy is a professor at George Washington University and a volunteer at the University of California San Diego OBGYN and reproductive sciences department.
Dr. Amy Park
Dr. Amy Park is the Section Head of Female Pelvic Medicine & Reconstructive Surgery at the Cleveland Clinic, and a co-host of the BackTable OBGYN Podcast.
Dr. Mark Hoffman
Dr. Mark Hoffman is a minimally invasive gynecologic surgeon at the University of Kentucky.
Cite This Podcast
BackTable, LLC (Producer). (2023, October 26). Ep. 37 – In-Depth: Endometrial Ablation [Audio podcast]. Retrieved from https://www.backtable.com
Disclaimer: The Materials available on BackTable.com are for informational and educational purposes only and are not a substitute for the professional judgment of a healthcare professional in diagnosing and treating patients. The opinions expressed by participants of the BackTable Podcast belong solely to the participants, and do not necessarily reflect the views of BackTable.
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